Clinical TrialTreatment-Resistant Depression (TRD)KetamineCompleted

Behavioral and Electrophysiological Effects of Ketamine in Treatment-Resistant Depression

Observational case-control study (n=60; 30 TRD, 30 healthy controls) assessing EEG and behavioural measures 24 hours after a subanesthetic ketamine injection given as part of clinical care.

Target Enrollment
60 participants
Study Type
Phase NA observational
Design
Non-randomized

Detailed Description

This observational case-control study recruits 30 individuals with treatment-resistant major depressive disorder who are already scheduled to receive clinical ketamine treatment and 30 demographically matched healthy controls. Primary assessments include resting-state EEG, cognitive-control tasks, and reward-learning measures performed 24 hours after ketamine administration.

Participants undergo questionnaires, urine drug screening, and electrophysiological recording (EEG); eligibility is confirmed via structured clinical interview and depression scales (IDS-C30, QIDS, HDRS). Healthy controls must have no psychiatric history and no first-degree relative with mood or psychotic disorder.

Study Arms & Interventions

Current MDD

experimental

Participants with current major depressive disorder receiving ketamine as part of standard clinical care.

Interventions

  • Ketamine
    via IV• single dose

    Single subanesthetic ketamine infusion administered as part of clinical care; EEG and assessments at 24 hours post-injection.

Healthy Controls

inactive

Demographically matched healthy control subjects with no history of clinical depression or other psychiatric disorder.

Participants

Ages
18 – 70
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria (MDD Subjects):
  • All genders, races, and ethnic origins, aged between 18 and 70;
  • DSM-5 diagnostic criteria for MDD (diagnosed with the use of the Structured Clinical Interview for DSM-5 (SCID-5));
  • A score of ≥32 on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30).
  • Capable of providing written informed consent, and fluent in English;
  • Right-handed;
  • Treatment Resistant (as assessed using the MGH Antidepressant Response Questionnaire)
  • Have already decided to receive ketamine treatment as part of their standard clinical care
  • Inclusion Criteria (Control Subjects):
  • All genders, races, and ethnic origins, aged between 18 and 70;
  • Absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse), as assessed by subject history and a structured clinical interview (SCID-I/NP);
  • A baseline Quick Inventory of Depressive Symptomatology (QIDS) score ≤ 5;
  • A baseline Hamilton Depression Rating Scale (HDRS) score ≤ 7;
  • Capable of providing written informed consent, and fluent in English;
  • Right-handed;
  • No first-degree relative with mood or psychotic disorder.

Exclusion Criteria

  • Exclusion Criteria (All Subjects):
  • Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease;
  • History of seizure disorder;
  • History or current diagnosis of any of the following DSM-5 psychiatric illnesses: schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, substance abuse disorder;
  • Clinical or laboratory evidence of hypothyroidism, hyperthyroidism, or other thyroid disorder that is not controlled by medication;
  • Substance use assessed by physician as dangerous for ketamine treatment;
  • Untreated glaucoma;
  • Complex post-traumatic stress disorder (PTSD) with dissociation;
  • Patients with a lifetime history of electroconvulsive therapy (ECT).
  • Participants with a lifetime history of ketamine use.

Study Details

Locations

McLean Hospital — Belmont, Massachusetts, United States

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